MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)

Who is this study for? Adult patients with Isolated Ileocolic Crohn's Disease
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Study description - Patients will be randomized according to post-operative recurrence risk to either a high ligation of ileocolic artery or mesenteric sparing ileocolic resection for terminal ileal Crohn's disease. The primary endpoint 6-month endoscopic recurrence. Endpoints - Primary endpoint; 6 months Secondary endpoints at 1 and 5 years post ileocecal resection Study population - Adult Crohn's disease patients with medically refractory terminal ileal Crohn's disease undergoing a primary ileocecal resection. Study sites - Multicenter international study Description of study intervention - Randomized control trial of two operative techniques Operative approach of a high ligation of ileocolic artery as compared to mesenteric sparing for a primary ileocolic resection Participate duration - 5 years

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Males and females 18-65 years of age.

• Isolated ileocolic Crohn's disease of \<30 cm in length

• Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF, vedolizumab, ustekinumab therapy are permitted.

• Ability to comply with protocol

• Competent and able to provide written informed consent

• Medically refractory disease or inability to tolerate ongoing medical therapy

Locations
United States
California
Cedars-Sinai Hospital System
RECRUITING
Los Angeles
Stanford University School of Medicine
RECRUITING
Stanford
Florida
Cleveland Clinic Florida
RECRUITING
Weston
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Other Locations
Canada
Mt. Sinai
RECRUITING
Toronto
Italy
Humanitas
RECRUITING
Rozzano
United Kingdom
St Mark's Hospital and Academic Institution
NOT_YET_RECRUITING
Harrow
Contact Information
Primary
Allison Bayles, AA
ibdstemcelltherapy@ccf.org
216-444-0887
Backup
Alex VanDenBossche, BSN
ibdstemcelltherapy@ccf.org
216-445-3455
Time Frame
Start Date: 2020-07-28
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 181
Treatments
Active_comparator: high ligation of ileocolic artery
Randomized control trial of two operative techniques Operative approach of a high ligation of ileocolic artery as compared to mesenteric sparing for a primary ileocolic resection
Active_comparator: mesenteric sparing for a primary ileocolic resection
Randomized control trial of two operative techniques Operative approach of a high ligation of ileocolic artery as compared to mesenteric sparing for a primary ileocolic resection
Related Therapeutic Areas
Sponsors
Leads: The Cleveland Clinic

This content was sourced from clinicaltrials.gov